Many studies have shown that nosocomial (hospital-acquired) infections are a leading cause of death in the United States. One source of such infections involves the entry of bacteria into intraluminal access sites.
As explained in the background section of U.S. Pat. No. 7,834,328 to Redmond et al. (“Redmond”), one of the first interventions that occurs when a patient is admitted into a hospital is the placement of an intravenous access line (IV). This percutaneously-placed IV line gives the caregivers a direct path to the patient's bloodstream via a peripheral vein for rapid administration of fluids, medication or for drawing blood samples. In more serious cases, where direct access to a high blood flow supply is needed, for example, in chemotherapy delivery, temporary kidney dialysis or heart monitoring catheterization, a Central Venous Access Catheter (CVAC or Central Line) is inserted. This line is typically inserted percutaneously into a major branching vessel, frequently the subclavian vein, and then the distal segment of the catheter is directed into the superior vena cava.
Both peripheral and central catheterization procedures create an open pathway or lumen from an external access site into the bloodstream. This intraluminal access site provides an attachment point for various therapeutic or diagnostic medical devices, including, but not limited to, stopcocks, needle-less access sites, IV bags, infusion pumps, drug delivery pumps, kidney dialysis equipment, thermal dilution catheters, and the like. Unfortunately, this access site also provides an entry point for bacterial infections. Therefore, each time the access site is opened to accommodate the attachment of a medical device there is an opportunity for bacteria to enter the catheter lumen and be transferred into the bloodstream.
In addition to the contamination of the catheter lumen via the external access site, bacteria can also enter by the skin puncture and sub-cutaneous tract that is created by the catheter when the IV or CVAC is placed. Bacteria can then find their way down the outside wall of the catheter to its distal end, infecting the tract along the catheter wall as they migrate.
In an attempt to mitigate the serious problems identified in the preceding paragraphs, many prior art IV lines and CVACs use some type of molded plastic fitting at their proximal end terminated with a female Luer-lock or Luer-slip connector. These connectors must be closed by a Luer cap when not in use to prevent access site contamination. Each time the line is to be accessed, the Luer cap must be removed and discarded as it must be assumed that the outside of the Luer cap is contaminated and that once removed it is nearly impossible to prevent the male Luer configuration from touching a contaminated surface. Therefore, standard prior art infection control practice is to always replace the Luer cap whenever the line is accessed. This procedure is not only costly, but the removal and replacement process provides additional chances for bacteria to enter the lumen of the connector.
Redmond, as well as other prior techniques, is thus primarily concerned with bacterial infections that are caused by bacteria introduced into, and residing within, a Luer cap or other closure cap. To this end, Redmond discloses a substantially UV-C transparent closure cap for closing the access site, and an irradiating apparatus which fits over the transparent closure cap for irradiating the closure cap with UV-C radiation, thereby sterilizing the closure cap.
However, a drawback of the Redmond apparatus is that it requires the line to be capped, and thus cannot be sterilized while carrying a fluid to or from a patient. Further, some bacterial infections may be caused by bacteria that are not introduced via the closure cap, but rather from some point upstream of the access site. Moreover, bacteria may be introduced into a patient's body (whether into the blood stream, lungs, bladder or the like) through the fluid passing through the interior of a catheter.
See also U.S. Pat. No. 8,197,087, PCT Application Serial No. PCT/US2014/033207, and US Published Application US 2012/0053512.
Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.